Authors
Nikhil C Munshi, Larry D Anderson Jr, Nina Shah, Deepu Madduri, Jesús Berdeja, Sagar Lonial, Noopur Raje, Yi Lin, David Siegel, Albert Oriol, Philippe Moreau, Ibrahim Yakoub-Agha, Michel Delforge, Michele Cavo, Hermann Einsele, Hartmut Goldschmidt, Katja Weisel, Alessandro Rambaldi, Donna Reece, Fabio Petrocca, Monica Massaro, Jamie N Connarn, Shari Kaiser, Payal Patel, Liping Huang, Timothy B Campbell, Kristen Hege, Jesús San-Miguel
Publication date
2021/2/25
Journal
New England Journal of Medicine
Volume
384
Issue
8
Pages
705-716
Publisher
Massachusetts Medical Society
Description
Background
Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen–directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic effects in patients with relapsed and refractory multiple myeloma.
Methods
In this phase 2 study, we sought to confirm the efficacy and safety of ide-cel in patients with relapsed and refractory myeloma. Patients with disease after at least three previous regimens including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody were enrolled. Patients received ide-cel target doses of 150×106 to 450×106 CAR-positive (CAR+) T cells. The primary end point was an overall response (partial response or better); a key secondary end point was a complete response or better (comprising complete and stringent complete responses).
Results
Of 140 patients enrolled, 128 received ide-cel. At …
Scholar articles
NC Munshi, LD Anderson Jr, N Shah, D Madduri… - New England Journal of Medicine, 2021